Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

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Brief Title

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

Official Title

Study of Musical Perception and Post-operative Auditory Performance as a Function of the Depth of Stimulation in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy Single-center Randomized Cross-over Study

Brief Summary

      Main objective:

      Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL
      cochlear implant gives better results on musical perception if the depth of stimulation
      (stimulation or not of the apical areas) is greater.

      Secondary objectives:

      Evaluate the effect of stimulation depth on vocal audiometric results, results of
      differential frequency threshold test and on qualitative sound perception.
    

Detailed Description

      Introduction:

      Conventional stimulation strategies in cochlear implants (e.g. ACE, CIS) use the place of the
      electrode to code the frequency by sending low frequency information on the apical electrodes
      and high frequency information on the basal electrodes. The stimulation rate of the
      electrodes is constant.

      The pitch is only partially transmitted by these conventional strategies which would explain
      the poor results of cochlear implants in the perception of music.

      In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the
      low-frequency electrodes is related to the frequency of the sound and makes it possible to
      code the frequency information temporally.

      Rader & al. 2016 have studied the contribution of adding to the tonotopic coding of the
      frequency (classical strategy) a temporal coding of the information by varying the
      stimulation rate. The results obtained show that providing this frequency information by time
      coding makes it possible to obtain perceived pitch much closer to the expected pitch (of
      normal-hearing) and less variability, especially at low frequencies. With fixed stimulation
      rate (classical strategy) low frequencies are poorly coded, whereas with the variable
      stimulation rate they are better coded.

      In addition, Landsberger et al. [2018] studied in six subjects with a MED-EL implant the
      perception of a temporal coding according to the position of the electrodes with a long
      insertion: middle or apical position. The results seem to show that the temporal coding of
      the frequency would be more reliable than the spatial coding (related to the position of the
      electrode) at the apex, and the reverse on the electrodes in the middle position.

      Studies have shown that the FineHearing strategy can provide benefits over the classic HDCIS
      strategy in tasks involving the fundamental F0 such as speech recognition in noise (after a
      certain learning time) [Kleine Punte & al. 2014 ; Vermeire & al. 2010], the perception of
      music [Roy & al. 2015 ; Roy & al. 2016] or the perceived quality of pitch [Müller & al.
      2012].

      The results obtained seem to depend on the position of the electrode: a deep insertion to
      reach the apical zone of the cochlea would allow better coding of the information.

      MED-EL's FineHearing coding strategy with stimulation of the apical areas of the cochlea
      (long insertion of electrodes) could therefore allow better transmission of musical pitch and
      in particular improve the subjective quality of music compared to the same stimulation
      strategy without reaching the apical areas (short insertion).

      Objective of the study: The objective of the study is to evaluate if the FineHearing strategy
      of MED-EL with stimulation of the apical zones allows to better transmit musical pitch and in
      particular to improve the subjective quality of the music compared to the same stimulation
      strategy without apical stimulation.

      Main objective:

      Show that the FineHearing strategy of MED-EL with stimulation of the apical zones allows to
      obtain a better perceptual quality of music in newly implanted cochlear patients than the
      same strategy without apical stimulation.

      Secondary objectives:

        -  Evaluate differential frequency thresholds and correlation with qualitative perceptions
           of music.

        -  Evaluate the effect of the stimulation of the apical zones on the results of speech
           audiometry with the FineHearing strategy.

        -  Evaluate the effect of the stimulation of the apical zones on the subjective quality of
           sounds by questionnaire with the FineHearing strategy.

      Plan of study:

      it is a Single-center, randomized, double-blind, cross-over study
    


Study Type

Interventional


Primary Outcome

Qualitative measure of music with direct audio link

Secondary Outcome

 Qualitative measure of music

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated

Study Arms / Comparison Groups

 CI with FineHearing with 10 more apical electrodes activated then 10 more basal electrodes activated
Description:  Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated first during 1 month then FineHearing Strategy with 10 more basal electrodes activated during 1 month

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

32

Start Date

January 10, 2021

Completion Date

July 10, 2023

Primary Completion Date

July 10, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patient (≥ 18 years old) speaking French

          -  Patient who fulfils the criteria for cochlear implantation

          -  Patient with a postoperative insertion angle of the apical electrode > 450°

          -  Patient with 12 active electrodes on the day of activation.

        Exclusion Criteria:

          -  Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Isabelle Mosnier, Dr, (+33) 603592974, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04591093

Organization ID

MED-EL_FS_stimdepth_frenchstud


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Isabelle Mosnier, Dr, Principal Investigator, Service ORL, UF Implants auditifs et explorations fonctionnelles GH Pitié-Salpêtrière, APHP 6 Paris


Verification Date

October 2020